The Intensive Care Platform Trial (INCEPT)

The Intensive Care Platform Trial (INCEPT)

Among critically ill patients, many die, and many of the survivors and their family members struggle for years with reduced quality of life. Critically ill patients are treated in intensive care units (ICUs). Here, they receive life support, e.g., mechanical ventilation and advanced support of the circulation (heart and blood vessels) and kidneys. In addition, ICU patients receive many other treatments. It is, however, uncertain if all the treatments provide value for the patients. The desirable effects of many treatments are uncertain, and some may be wasteful or even harmful.

Clinical trials are necessary to validly assess the desirable and undesirable effects of different treatments. However, conventional clinical trials have limitations:

• They typically only assess a single question related to a single comparison of treatments at a time.
• They are often not very flexible, including with regards to the number of participants needed, and this increases the risk that a trial will end up as inconclusive.
• There is no or limited re-use or sharing of infrastructure across trials, leading to duplicate work and resource use.
• Trial participants do usually not benefit from the obtained knowledge before the trial concludes.
• Involvement of patients, family members, and other stakeholders is typically limited, which may decrease the relevance of the questions addressed.

With the Intensive Care Platform Trial (INCEPT), we aim to tackle these challenges by establishing a flexible platform trial that continuously learns from the obtained results. The platform trial may run forever with simultaneous and continuous assessment of many treatments. INCEPT will continuously learn from the accrued data and use these to improve the treatment of both participating and future patients. With INCEPT, we are also building a framework for thorough and extensive involvement of key stakeholders, including patients and family members. INCEPT will improve the way clinical trials are done and increase the probabilities that treatments are improved. This will:

• Directly improve outcomes for ICU patients.
• Relieve a strained healthcare system by discarding inefficient or harmful treatments.
• Ensure that new treatments are beneficial or cost-effective before implementation.
• Lower the costs and burdens of assessing more treatments in the critically ill.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Intensive Care Unit Patients; Intensive Care Patients
• Intervention / Treatment: Drug: Albumin; Other: No albumin use; Drug: LMWH in weight-adjusted dose; Drug: LMWH in fixed low dose; Drug: LMWH in fixed intermediate dose

Detailed Description

Background:

Randomised clinical trials (RCTs) are the gold standard for evaluating intervention effects, however, conventional RCTs are bureaucratic, costly, inflexible, and often inconclusive. Adaptive platform trials are increasingly used as they can reduce barriers and are more flexible, and thus come with a higher probability of obtaining conclusive results faster at lower costs.

Objectives:

The Intensive Care Platform Trial (INCEPT) will be used to assess the effects of interventions used in adults acutely admitted to the intensive care unit (ICU).

Design:

INCEPT is an investigator-initiated, pragmatic, randomised, embedded, multifactorial, international, adaptive platform trial. INCEPT uses adaptive stopping and arm-dropping rules, as well as fixed and response-adaptive randomisation. Specific domains may be either open label or blinded.

Domains and interventions:

Comparable groups of interventions will be nested in domains, which have conceptual similarities with stand-alone randomised trials. Domains will continuously be added to INCEPT and conducted following domain-specific appendices to the core protocol.

Inclusion and exclusion criteria:

Adults acutely admitted to the ICU will be screened if they are eligible for at least one active domain. The only platform-level exclusion criteria are 1) informed consent after inclusion expected to be unobtainable and 2) patients admitted under coercive measures. Additional inclusion and exclusion criteria will be domain-specific.

Stakeholder involvement:

Stakeholder involvement is central in INCEPT and ensured through a central advisory board comprising various key stakeholders, and consultations with national and international research panels consisting of ICU survivors, family members, clinicians, and researchers. Stakeholders will be involved in the development of the overall platform trial and specific domains with pre-specified minimum requirements for involvement.

Outcomes:

Each domain will use one of the core outcomes (defined elsewhere in the registration) as the primary outcome and the guiding outcome driving all adaptations.

Statistical methods Primary analyses will generally be conducted in the intention-to-treat population of each domain. INCEPT primarily uses Bayesian statistical methods with neutral priors conveying either minimal information or some scepticism, although specific domains may use conventional, frequentist statistical methods. Outcomes will generally be analysed using logistic and linear regression models adjusted for pre-specified anticipated prognostic baseline characteristics, followed by calculation of sample-average estimates and intervention effects using G-computation. Results will be presented for each intervention and comparisons presented on both the absolute (risk differences and mean differences) and relative (risk ratios and ratios of means) scales with 95% credible intervals and probabilities of superiority. INCEPT will generally use constant, symmetric stopping rules for superiority/inferiority based on the guiding outcome; domains may use stopping rules for practical equivalence or futility based on the posterior distribution of the guiding outcome on the absolute scale. All stopping rules will be binding. Response-adaptive randomisation, either with or without restrictions, may be used based on the posterior distribution for the guiding outcome. Missing data will be multiply imputed. Additional secondary analyses (e.g., per-protocol analyses), sensitivity analyses, and analyses of heterogeneity in intervention effects according to pre-defined baseline characteristics may be specified for each domain and undertaken once a domain has stopped. Domains will be designed and evaluated using statistical simulation.

• Study Type: Interventional
• Enrollment (Estimated): 10000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anders Perner, Professor; Phone Number: 004535458333; Email: anders.perner@regionh.dk
• Study Contact Backup: Name: Morten H Moeller, Professor; Phone Number: 004535458685; Email: morten.hylander.moeller@regionh.dk

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Not yet recruiting
    • Anaesthesia, Hospital Sønderjylland
    • Contact: Rajesh P Bhavsar, MD; Phone Number: 004579970000; Email: rajesh.prabhakar.bhavsar@rsyd.dk
    • Principal Investigator: Rajesh P Bhavsar, MD
  • Aalborg, Denmark, 9000
    • Recruiting
    • Department of Anaesthesia and Intensive Care, Aalborg University Hospital
    • Contact: Bodil S Rasmussen, Professor, MD, PhD; Phone Number: 004597661864; Email: bodil.steen.rasmussen@rn.dk
    • Contact: Olav L Schjørring, MD, PhD; Email: o.schjoerring@rn.dk
    • Principal Investigator: Bodil S Rasmussen, MD, PhD
  • Aarhus, Denmark, 8200
    • Recruiting
    • Department of Intensive Care Nord , Aarhus University Hospital
    • Contact: Klaus U Koch, MD, Consoultant; Phone Number: 004561686674
    • Principal Investigator: Klaus U Koch, MD, Consultant
  • Aarhus, Denmark, 8200
    • Recruiting
    • Department of Intensive Care Øst, Aarhus University Hospital
    • Contact: Asger Granfeldt, MD, Professor; Phone Number: 004529720155; Email: asgegran@rm.dk
    • Principal Investigator: Asger Granfeldt, MD, Professor
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet
    • Contact: Anders Perner, Professor; Phone Number: 004535458333; Email: anders.perner@regionh.dk
    • Contact: Morten H Moeller, Professor; Phone Number: 004535458685; Email: morten.hylander.moeller@regionh.dk
    • Sub-Investigator: Anders Granholm, MD, PhD
  • Copenhagen, Denmark, 2100
    • Not yet recruiting
    • Department of Cardiothoracic Anaesthesia and Intensive care, Copenhagen Universisty Hospital - Rigshospitalet
    • Contact: Peter B Hjortrup, MD, PhD; Phone Number: 004535451217; Email: peter.buhl.hjortrup@regionh.dk
    • Principal Investigator: Peter B Hjortrup, MD, PhD
  • Copenhagen, Denmark, 2100
    • Not yet recruiting
    • Neuroanaesthesiology, Copenhagen University Hospital - Rigshospitalet
    • Contact: Kirsten Møller, MD, PhD, DMSc, Professor; Phone Number: 004535451616; Email: kirsten.moeller.01@regionh.dk
    • Contact: Email: kirsten.moeller.01@regionh.dk
    • Principal Investigator: Kirsten Møller, MD, PhD, DMSc, Professor
  • Copenhagen, Denmark, 2400
    • Recruiting
    • Department of anesthesiology and intensive care, Bispebjerg-Frederiksberg Hospital
    • Contact: Nanna Reitter, MD; Phone Number: 004540146658; Email: nanna.reitter@regionh.dk
    • Principal Investigator: Nanna Reitter, MD
  • Esbjerg, Denmark, 6700
    • Not yet recruiting
    • Esbjerg Hospital
    • Contact: Anders Storgaard, MD; Phone Number: 004579182645; Email: anders.storgaard@rsyd.dk
  • Herlev, Denmark, 2730
    • Not yet recruiting
    • Department of Anesthesiology and Intensive Care, Copenhagen University Hospital Herlev
    • Contact: Anne S Andreasen, MD, PhD; Phone Number: 004538681875; Email: Anne.sofie.andreasen@regionh.dk
    • Principal Investigator: Anne S Andreasen, MD, PhD
  • Herning, Denmark, 7400
    • Recruiting
    • Department of Anaesthesiology and Intensive Care, Gødstrup Hospital
    • Contact: Iben S Darfelt, MD; Phone Number: 004548310086; Email: ibedar@rm.dk
    • Principal Investigator: Iben S Darfelt, MD
  • Hillerød, Denmark, 3400
    • Recruiting
    • Department of Anaesthesia and Intensive Care Medicine, Copenhagen University Hospital - North Zealand
    • Contact: Morten H Bestle, MD; Phone Number: 004541951195; Email: morten.bestle@regionh.dk
    • Principal Investigator: Morten H Bestle, MD
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Anaesthesiology and Intensive Care, Amager and Hvidovre Hospital
    • Contact: Ronni TR Plovsing, MD, PhD; Phone Number: 004538620721; Email: ronni.thermann.reitz.plovsing.01@regionh.dk
    • Principal Investigator: Ronni TR Plovsing, MD, PhD
  • Kolding, Denmark, 6000
    • Recruiting
    • Department of Anesthesia and intensive care medicine, Kolding Hospital
    • Contact: Anne C Brøchner, MD, Consultant; Phone Number: 004529464468; Email: Anne.craveiro.broechner@rsyd.dk
    • Principal Investigator: Anne C Brøchner, MD, Consultant
  • Køge, Denmark, 4600
    • Recruiting
    • Department of Anesthesia, Zealand University Hospital
    • Contact: Lars Peter K Andersen, MD, Ph.D; Phone Number: +45 31518908; Email: lpka@regionsjaelland.dk
    • Contact: Louise S Herløv, Project nurse; Phone Number: +45 47 32 63 11; Email: lherl@regionsjaelland.dk
    • Principal Investigator: Lars Peter K Andersen, MD, Ph.D
  • Nykøbing Falster, Denmark, 4800
    • Not yet recruiting
    • Anesthesiology (ICU), Zealand University Hospital, Nykøbing Falster
    • Contact: Hans Fjeldsøe-Nielsen, MD; Phone Number: 004556515607; Email: hafj@regionsjaelland.dk
    • Principal Investigator: Hans Fjeldsøe-Nielsen, MD
  • Odense, Denmark, 5000
    • Recruiting
    • Department of Anesthesiology and Intensive Care, Odense University Hospital
    • Contact: Jens Michelsen, MD; Phone Number: 004565413365; Email: Jens.michelsen3@rsyd.dk
    • Principal Investigator: Jens Michelsen, MD
  • Randers, Denmark, 8930
    • Recruiting
    • Operation og Intensiv, Regional Hospital Randers
    • Contact: Marianne L Vang, MD; Phone Number: 004578420505; Email: marivang@rm.dk
    • Principal Investigator: Marianne L Vang, MD
  • Slagelse, Denmark, 4200
    • Recruiting
    • Intensive care, Slagelse Hospital
    • Contact: Anne G Vedel, MD, Senior Registrar; Phone Number: 004560660882; Email: agse@regionsjaelland.dk
    • Contact: Susanne A Iversen, Leading Physician; Phone Number: 004524951801; Email: saiv@regionsjaelland.dk
    • Principal Investigator: Anne G Vedel, MD, Senior registrar
  • Svendborg, Denmark, 5700
    • Recruiting
    • Department. of Anesthesiology and Intensive Care Medicine
    • Contact: Peter M Hansen, MD, Consultant; Phone Number: +4520629319; Email: peter.martin.hansen@rsyd.dk
    • Principal Investigator: Peter M Hansen, MD, Consultant
  • Viborg, Denmark, 8800
    • Recruiting
    • Department of Anaesthesiology and Intensive Care, Regional Hospital Viborg
    • Contact: Christoffer G Sølling, MD, PhD; Phone Number: 004561787862; Email: chrisl@rm.dk
    • Principal Investigator: Christoffer G Sølling, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

The general eligibility criteria below apply to INCEPT as a whole and thus to all domains. Domains may impose domain-specific eligibility criteria that restrict the population eligible for that domain further, but domains are not allowed to broaden the general eligibility criteria. Domain-specific eligibility criteria always apply to all arms in a domain.

PLATFORM INCLUSION CRITERIA:

• Adult patient (≥18 years old) acutely admitted to the ICU. This includes ICU admissions after emergency surgery, unplanned ICU admissions after elective surgery, and prolonged ICU admissions due to complications after elective surgery (i.e., admissions occurring or being prolonged due to an unexpected, worsened condition, but excluding planned ICU admissions after elective surgery without clinical deterioration).
• Eligible for at least one active domain.

PLATFORM EXCLUSION CRITERIA:

• Informed consent following inclusion expected to be unobtainable (e.g., known previous objections to participation).
• Patient is under coercive measures (e.g., ongoing involuntary hospital stay or under the jurisdiction of correctional authorities).

Patients who have previously been included in INCEPT may only be included again during new ICU admissions but may only be randomised to domains in which they have not previously been randomised.

DOMAIN-SPECIFIC ELIGIBLE CRITERIA:

Each domain may have additional eligibility criteria. Refer to the study website for more information (www.incept.dk).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Albumin; Use of albumin in ICU during circulatory failure in addition to crystalloids (resuscitation) and for substitution in case of suspected or overt albumin loss or plasma albumin levels ≤25 g/L	Drug: Albumin; Albumin should be used for the following indications: 1. During circulatory failure in addition to crystalloids (resuscitation). 2. For substitution in case of: suspected or overt albumin loss OR P-albumin levels below or equal to 25 g/L. Decisions around timing, volume, and concentration of albumin, and its use for other indications, are at the clinician's discretion. P-albumin should be measured according to local practice.
Other: No albumin use; No albumin is to be used in ICU unless specific events occur	Other: No albumin use; Albumin should not be used. In case of the following special circumstances, albumin may be considered: 1. Large ascites drainage (i.e., equal to or more than 1 L tapped) 2. Spontaneous bacterial peritonitis 3. Hepatorenal syndrome.
Experimental: Low-molecular-weight heparin for thromboprophylaxis in weight-adjusted dose; Use of low-molecular-weight heparin for thromboprophylaxis in weight-adjusted dose during ICU stay	Drug: LMWH in weight-adjusted dose; Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a weight-adjusted dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and/or chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.
Active Comparator: Low-molecular-weight heparin for thromboprophylaxis in fixed low dose; Use of low-molecular-weight heparin for thromboprophylaxis in fixed low dose during ICU stay	Drug: LMWH in fixed low dose; Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a fixed low dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and/or chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.
Active Comparator: Low-molecular-weight heparin for thromboprophylaxis in fixed intermediate dose; Use of low-molecular-weight heparin for thromboprophylaxis in fixed intermediate dose during ICU stay	Drug: LMWH in fixed intermediate dose; Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a fixed intermediate dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and/or chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One of the INCEPT core outcomes (varying between domains)	Each domain in INCEPT will use one of the core outcomes; 1. All-cause 30-day mortality. 2. All-cause 90-day mortality. 3. All-cause 180-day mortality. 4. Days alive without life support at day 30. 5. Days alive without life support at day 90. 6. Days alive out of hospital at day 30. 7. Days alive out of hospital at day 90. 8. Days free of delirium at day 30. 9. EQ VAS (Health-Related Quality of Life) at day 180. 10. EQ-5D-5L index values (Health-related quality of life) at day 180. 11. Cognitive function at day 180 (all described under "secondary outcomes").	From randomisation to 30-180 days after randomisation.
Days alive without life support at day 30 (Albumin domain)	Days alive without the use of life support, with life support defined as invasive mechanical ventilation (≥1 hour of ventilation through a cuffed tube), continuous (i.e., ≥1 hour) use of vasopressors/inotropes, use of renal replacement therapy (including any form of in-hospital renal replacement therapy [e.g., haemodialysis, haemofiltration, or haemodiafiltration], continuously or intermittently, and including days in between intermittent renal replacement therapy; pauses between renal replacement therapy of up to three days will be considered as days receiving intermittent renal replacement therapy) at hospitals. Integer (0-30 overall; 0-29 in domains with life support at baseline as an eligibility criterion).	From randomisation to 30 days after randomisation.
Days alive and out of hospital at day 30 (Thromboprophylaxis domain)	Days alive and out of hospital. Rehabilitation facilities and nursing homes do not count as hospitals. Integer 0-29.	From randomisation to 30 days after randomisation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause 30-day mortality	All-cause, fixed-time mortality. Binary.	30 days after randomisation.
All-cause 90-day mortality	All-cause, fixed-time mortality. Binary.	90 days after randomisation.
All-cause 180-day mortality	All-cause, fixed-time mortality. Binary.	180 days after randomisation.
Days alive without life support at day 30	Days alive without the use of life support, with life support defined as invasive mechanical ventilation (≥1 hour of ventilation through a cuffed tube), continuous (i.e., ≥1 hour) use of vasopressors/inotropes, use of renal replacement therapy (including any form of in-hospital renal replacement therapy [e.g., haemodialysis, haemofiltration, or haemodiafiltration], continuously or intermittently, and including days in between intermittent renal replacement therapy; pauses between renal replacement therapy of up to three days will be considered as days receiving intermittent renal replacement therapy) at hospitals. Integer (0-30 overall; 0-29 in domains with life support at baseline as an eligibility criterion).	From randomisation to 30 days after randomisation.
Days alive without life support at day 90	Days alive without the use of life support, with life support defined as invasive mechanical ventilation (≥1 hour of ventilation through a cuffed tube), continuous (i.e., ≥1 hour) use of vasopressors/inotropes, use of renal replacement therapy (including any form of in-hospital renal replacement therapy [e.g., haemodialysis, haemofiltration, or haemodiafiltration], continuously or intermittently, and including days in between intermittent renal replacement therapy; pauses between renal replacement therapy of up to three days will be considered as days receiving intermittent renal replacement therapy) at hospitals. Integer (0-90 overall; 0-89 in domains with life support at baseline as an eligibility criterion).	From randomisation to 90 days after randomisation.
Days alive out of hospital at day 30	Days alive and out of hospital. Rehabilitation facilities and nursing homes do not count as hospitals. Integer 0-29.	From randomisation to 30 days after randomisation.
Days alive out of hospital at day 90	Days alive and out of hospital. Rehabilitation facilities and nursing homes do not count as hospitals. Integer 0-89.	From randomisation to 90 days after randomisation.
Days free of delirium at day 30	Days free of delirium. Days are not considered free of delirium in case of any of the following: a) any registered positive delirium score with a validated screening tool (Confusion Assessment Method for the Intensive Care Unit [CAM-ICU], CAM-ICU-7 or Intensive Care Delirium Screening Checklist [ICDSC]) b) new treatment with antipsychotics (any administration of haloperidol, olanzapine, or quetiapine in participants not receiving either of these at the time of index hospital admission) c) delirium status not evaluable due to mortality or registered coma. Integer (0-30 overall; 0-29 in domains with delirium at baseline as an eligibility criterion).	From randomisation to 30 days after randomisation.
EQ-5D-5L index values (Health-Related Quality of Life) at day 180	EQ-5D-5L instrument with responses across five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five response levels each. Used with a value set to calculate index values anchored at 1 (perfect health) and 0 (a health state considered as bad as being dead) with index values below 0 representing health states worse than death. Preferably completed by participants, but completed by proxies if participants are unable to answer (using the proxy-participant perspective, i.e., the proxy will answer from the participant's perspective as the limited, indirect data available indicates that this perspective may better correspond to the participant's own response, if available). Decimal number (minimum values depend on value sets used, e.g., -0.758 with the Danish value set; maximum value: 1.000).	180 days after randomisation (+/- 14 days).
EQ VAS (Health-Related Quality of Life) at day 180	A visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), part of the EQ-5D-5L instrument	180 days after randomisation (+/- 14 days).
Cognitive function at day 180	Montreal Cognitive Assessment test 5-minute version, v2.1 ("Mini MoCA"), ranging from 0 points (worst) to 15 points (best).	180 days after randomisation (+/- 14 days).
Thromboprophylaxis domain specific secondary outcomes	The number of participants with one or more domain-specific secondary outcomes, i.e., venous thromboembolism or major bleeding as specified in the domain-specific appendix.	30 days (matching the primary and guiding outcome) and 90 days (matching the maximum intervention period).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Albumin domain-specific safety outcomes	Albumin domain: The number of participants with one or more safety outcomes, i.e. severe anaphylatic reaction or major bleedings as specified in the domain specific appendix.	30 days (matching the primary and guiding outcome) and 90 days (matching the maximum intervention period.
Thromboprophylaxis domain-specific safety outcomes	The number of participants with one or more safety outcomes, i.e. severe anaphylactic reaction to LMWH or heparin-induced thrombocytopenia as specified in the domain specific appendix.	30 days (matching the primary and guiding outcome) and 90 days (matching the maximum intervention period).

Collaborators and Investigators

• Sponsor: Anders Perner
• Collaborators: Odense University Hospital; Karolinska Institutet; Zealand University Hospital; Oslo University Hospital; Aarhus University Hospital; Rigshospitalet, Denmark; University of Copenhagen; University Medical Center Groningen; University Hospital, Basel, Switzerland; Bispebjerg Hospital; Herlev Hospital; Tampere University; Region Capital Denmark; Hillerod Hospital, Denmark; Steno Diabetes Center Copenhagen; Aalborg University Hospital; Gødstrup Hospital; Copenhagen University Hospital, Hvidovre; Slagelse Hospital; Kolding Sygehus; Region Zealand; Viborg Regional Hospital; Randers Regional Hospital; North Denmark Region; Collaboration of Research in Intensive Care; Danish Intensive Care Database; The National University Hospital of Iceland
• Investigators: Study Chair: Anders Perner, Professor, Copenhagen University Hospital - Rigshospitalet, Department of Intensive Care; Principal Investigator: Anders Granholm, MD, Copenhagen University Hospital - Rigshospitalet, Department of Intensive Care; Principal Investigator: Morten H Moeller, Professor, Copenhagen University Hospital - Rigshospitalet, Department of Intensive Care

Publications and helpful links

Helpful Links

• Trial website - core protocol and domain-specific appendices will be made available here once approved.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2025
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Intensive care unit; Critical illness; Intensive care; Platform trial; Clinical platform trial
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; Amino Acids, Peptides, and Proteins; Proteins; Carbohydrates; Heparin; Glycosaminoglycans; Polysaccharides; Heparin, Low-Molecular-Weight; Albumins
• Other Study ID Numbers: RH-ITA-2024-516208-41-00; 2024-516208-41-00 (Ctis); U1111-1313-8171 (Other Identifier: World Health Organization - Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: An anonymised version of the final dataset (without personal, identifiable information, with timestamps replaced by relative time differences with respect to the time of randomisation, and other measures as deemed relevant) in each domain may be shared with other researchers following a reasonable request (i.e., a research proposal outlining the objectives, methodologies, and plans for data usage) and subsequent approval by the platform and domain management committees. Any sharing of data that is not considered anonymised will be after the necessary approvals; alternatively, aggregation, scrambling, or synthetic datasets (i.e., datasets with similar structure and attempts to preserve the overall relationships between variables as the original dataset) may be shared.
• IPD Sharing Time Frame: For each domain, data will generally only be shared after a grace period of at least 9 months following initial publication of results based on the data. Approved researchers will sign appropriate agreements to ensure compliance with the approved purpose and ethical and eventual legal requirements.
• IPD Sharing Access Criteria: Described in the core protocol which will be available at www.incept.dk once the trial has been approved.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No